More than a year ago, we explained the main benefits of the FDA eSTAR Program for 510(k) and De Novo filings. This information remains accurate, and is more relevant than ever because starting October 1, 2023, all 510(k) submissions (barring specified exemptions) must be submitted using the eSTAR. Exemptions may be found in the FDA Guidance titled “Electronic Submission Template for Medical Device 510(k) Submissions.” While the eSTAR will become mandatory for 510(k)s, it will remain voluntary for De Novo filings.
Since our last post, there was a new addition to the eSTAR family called the “PreSTAR.” The PreSTAR is intended to be used for Early Submission Requests for both IVD and non-IVD devices. For now, the PreSTAR can only be used for Pre-Subs, but it is expected to be expanded to include Submission Issue Requests, Study Risk Determination, PMA 100-Day Meeting requests and more. The PreSTAR is also voluntary and is still considered a Beta Version. If you have feedback or find malfunctions/errors, the FDA asks you to contact eSubPilot@fda.hhs.gov.
Medical Device companies are keenly aware of the difficulties and confusion that can surround medical device 510(k) and De Novo filings. With the Voluntary eSTAR Program, the uncertainty around medical device submissions can be a thing of the past.
What is eSTAR, and what is it used for?
The Voluntary eSTAR Program is a secondary way of completing medical device submissions. It uses an interactive PDF form to guide users through the process of completing and submitting their 510(k) or De Novo filings. The same eSTAR PDF is used for both 510(k) and De Novo filings and is free to use for all submitters. However, eSTAR cannot currently be used for combination product submissions.
How does eSTAR differ from typical methods of filing?
There are three main benefits that can be derived from using eSTAR over traditional methods of medical device submissions:
- The ability to quickly see that your submission is complete. If you have completed your eSTAR filing correctly, a status message at the top of the PDF will read “eSTAR Complete.” Throughout the completion of the submission, the eSTAR PDF will indicate when each section is completed. The form is also automated and will add or remove sections based on requirements for your submission.
- Filing with eSTAR reduces the documentation required to be added by the submitter into the submission. There are no additional FDA-provided forms (such as the Medical Device User Fee Cover Sheet) required to be filled out and included, as these are built into the interactive PDF.
- Submission packages are more streamlined with eSTAR. For traditional filing methods, the eCOPY Program must be followed when uploading documents to a flash drive, CD, or DVD. Maximum file size is 50MB for each file in the submission, and incorrect naming conventions for the files could result in the FDA refusing to accept the submission during the RTA review. With eSTAR, all that needs to be included in the submission package sent to the FDA is the eSTAR PDF saved onto a flash drive, CD, or DVD, and a printed cover letter. There is no need to follow the eCOPY Program guidelines as only one file (with embedded attachments) is provided.
What are the typical review timelines?
You can typically expect the following review timelines from the FDA for traditional submissions:
- RTA review completed within 15 days
- Substantive Review completed within 60 days
- Decision Letter sent 90 days from date the submission was received (not including review holds due to AI requests)
For Additional Information (AI) Requests, you have 180 days to submit additional requested documents/information.
For eSTAR filings, these review timelines are the same, minus the RTA review that does not need to be completed. This likely speeds up the review process and turnaround time for a decision letter.
If your organization needs guidance in preparing for their first 510(k) submission, whether it be in the form of a typical 510(k) Submission or a 510(k) eSTAR filing, Rook’s expansive, experienced team of quality consultants is prepared to assist you. Look to Rook to learn more!